Endoluminal prosthesis comprising a valve replacement and at least one fenestration

ABSTRACT

An endoluminal prosthesis comprises a graft having a tubular body comprising proximal and distal ends, and a valve replacement disposed between the proximal and distal ends of the graft. At least one stent is coupled to the graft and has a contracted delivery state and an expanded state for maintaining patency within a portion of the graft. At least one fenestration is disposed in a sidewall of the graft at a location distal to the valve replacement. In one embodiment, the at least one fenestration is pivotable in any direction away from an axis perpendicular to a longitudinal axis of the prosthesis.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. Utility patentapplication Ser. No. 13/213,349, filed Aug. 19, 2011 and entitled“Prosthesis Having Pivoting Fenestration,” which claims priority to U.S.Provisional Patent Application Ser. No. 61/375,815, filed Aug. 21, 2010,each of which are incorporated herein by reference in their entirety.

BACKGROUND

The functional vessels of human and animal bodies, such as blood vesselsand ducts, occasionally weaken or even rupture. For example, the aorticwall can weaken, resulting in an aneurysm, or it may develop a tear inone of the layers of the aortic wall resulting in an aortic dissection.

One common surgical intervention for weakened, aneurysmal or rupturedpassageways or ducts involves the use of an endoluminal prosthesis toprovide some or all of the functionality of the original, healthypassageway or duct and/or preserve any remaining vascular integrity byreplacing a length of the existing passageway or duct wall that spansthe site of failure or defect. Endoluminal prostheses may be of aunitary construction or may be comprised of multiple prosthetic modules.They also may be a single tubular device or a bifurcated branchingdevice depending on the desired application.

In many cases, however, the damaged or defected portion of thevasculature may include a branch vessel branching from the main vessel.For example, in the case of the abdominal aorta, there are at leastthree major branch vessels, including the celiac, mesenteric, and renalarteries, as well as other others, leading to various other body organs.Thus, when the damaged portion of the vessel includes one or more ofthese branch vessels, some accommodation must be made to ensure that theprosthesis does not block or hinder blood flow through the branchvessel. In many instances, there may in insufficient healthy tissue inthe aorta near the branching vessels adequately seal a prosthesiswithout partially or completely blocking one or more of the branchingvessels.

SUMMARY

An endoluminal prosthesis comprises a graft having a tubular bodycomprising proximal and distal ends, and a valve replacement disposedbetween the proximal and distal ends of the graft. At least one stent iscoupled to the graft and has a contracted delivery state and an expandedstate for maintaining patency within a portion of the graft. At leastone fenestration is disposed in a sidewall of the graft at a locationdistal to the valve replacement.

In one embodiment, the at least one fenestration is pivotable in anydirection away from an axis perpendicular to a longitudinal axis of theprosthesis. There may be a first perimeter having a first diameter andsurrounding the at least one fenestration, a band of flexible materialattached to and surrounding the first perimeter and having a flexibleframe, and a second perimeter attached to and surrounding the band offlexible material and having a second diameter greater than the firstperimeter diameter. The band of material has a first diametersubstantially the same as the first perimeter diameter and a seconddiameter substantially the same as the diameter of the second perimeter.The diameter of the band of material decreases in a direction away fromthe surface of the graft from the second perimeter to the firstperimeter.

In exemplary embodiments, the band of material has a concave or convexorientation relative to the surface of the graft. The band of materialmay be configured to independently move between an interior surface ofthe graft and an exterior surface of the graft.

In one embodiment, first and second fenestrations may be disposed in thegraft at locations between about 90 and about 270 degrees apart. A firstbranch vessel prosthesis may extend between the first fenestration and aright coronary artery in a deployed state, and a second branch vesselprosthesis may extend between the second fenestration and a leftcoronary artery in the deployed state.

The valve replacement may comprise an artificial valve having atricuspid shape. The valve replacement may be located at the proximalend of the graft, and one or more barbs extend radially outward from theproximal end of the graft.

Other systems, methods, features and advantages of the invention willbe, or will become, apparent to one with skill in the art uponexamination of the following figures and detailed description. It isintended that all such additional systems, methods, features andadvantages be within the scope of the invention, and be encompassed bythe following claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention can be better understood with reference to the followingdrawings and description. The components in the figures are notnecessarily to scale, emphasis instead being placed upon illustratingthe principles of the invention. Moreover, in the figures, likereferenced numerals designate corresponding parts throughout thedifferent views.

FIG. 1 shows a perspective view of a fenestrated prosthesis havingpivotable fenestrations concave (internal) pivotable fenestrations.

FIG. 2 is a partial and internal view of the prosthesis of FIG. 1.

FIG. 3 shows a perspective view of a fenestrated prosthesis havingpivotable fenestrations convex (external) pivotable fenestrations.

FIG. 4 is a partial and internal view of the prosthesis of FIG. 3.

FIG. 5 shows another fenestrated prosthesis having pivotablefenestrations concave (internal) pivotable fenestrations.

FIG. 6 is an enlarged perspective view of the pivotable fenestrationshown FIG. 5.

FIG. 7 shows a fenestrated prosthesis having imageable markers andreinforcement frames.

FIG. 8 is another partial and internal view of an internal pivotablefenestration.

FIG. 9 is a partial, cross-sectional view of a portion of a prosthesishaving a pivotable fenestration.

FIG. 10 shows an interior view of a pivotable fenestration where thefenestration is disposed within the lumen of the prosthesis.

FIG. 11 shows an exterior view of a pivotable fenestration where thefenestration is disposed within the lumen of the prosthesis.

FIG. 12 is a prosthesis having a protrusion of graft material to form afenestration and an extension.

FIG. 13 is a fenestrated prosthesis that has been deployed within adiseased vessel, such as the aorta, where branch vessel prostheses aredeployed within the branch vessels.

FIG. 14 shows a branch vessel prosthesis deployed in a secondary branchvessel, where the branch vessel prosthesis is deployed in a right branchvessel positioned lower than its corresponding left branch vessel.

FIG. 15 shows a branch vessel prosthesis deployed in a secondary branchvessel, where the branch vessel prosthesis is deployed in a right branchvessel positioned higher than its corresponding left branch vessel.

FIG. 16 is a side view of an alternative endoluminal prosthesiscomprising a valve replacement.

FIGS. 17A-17B are, respectively, top and bottom views of the endoluminalprosthesis of FIG. 16.

FIGS. 18 and 19 are side views of an exemplary delivery system that maybe used to deliver the endoluminal prosthesis of FIG. 16.

FIG. 20 is a schematic view of illustrating deployment of theendoluminal prosthesis of FIG. 16 in a patient's anatomy.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present disclosure relates to an endoluminal prosthesis, such as astent graft that includes one or more fenestrations to accommodateendovascular disease, such as an aneurysm in cases where one or moreside branches is involved, and a side branch prosthesis is deployedwithin the fenestration to permit fluid flow from the endoluminalprosthesis into the branch vessel. The prosthesis includes fenestrationsthat pivot as needed to accommodate the dynamic geometry of the aorticbranches. In various aspects shown and described in more detail below,for example, one or more pivotable fenestrations provided on aprosthesis lie outside the surface plane of the body of the prosthesisand will allow a branch vessel stent, graft or stent-graft that has beenplaced in the fenestration to pivot into a variety of orientationsrequired to meet and seal the branch vessel device in the branch vessel.The orientation of the fenestrations may dynamically change over time asneeded by changing anatomy.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood to one of ordinary skill inthe art to which this invention belongs.

The term “distal” means a location or direction that is, or a portion ofa device that when implanted is further downstream in the direction ofor with respect to blood flow.

The term “proximal” means a location or direction that is, or a portionof a device that when implanted is further upstream in the direction ofor with respect to blood flow.

The term “fenestration” means an opening provided through a surface of aprosthesis from the interior of the prosthesis to the exterior of theprostheses and may have a variety of geometries, including circular,semi-circular, oval, oblong, as well as other geometries.

The term “biocompatible” refers to a material that is substantiallynon-toxic in the in vivo environment of its intended use, and that isnot substantially rejected by the patient's physiological system (i.e.,is non-antigenic). Examples of biocompatible materials from whichtextile graft material can be formed include, without limitation,polyesters, such as polyethylene terephthalate; fluorinated polymers,such as polytetrafluoroethylene (PTFE) and fibers of expanded PTFE, andpolyurethanes. In addition, materials that are not inherentlybiocompatible may be subjected to surface modifications in order torender the materials biocompatible. Examples of surface modificationsinclude graft polymerization of biocompatible polymers on the materialssurface, coating of the surface with a crosslinked biocompatiblepolymer, chemical modification with biocompatible functional groups, andimmobilization of a compatibilizing agent such as heparin or otherbiocompatible substances. Thus, any fibrous material having sufficientstrength to survive in the in vivo environment may be used to form atextile graft, provided the final textile is biocompatible. Fiberssuitable for making textile grafts include polyethylene, polypropylene,polyaramids, polyacrylonitrile, nylon, and cellulose, in addition to thepolyesters, fluorinated polymers, and polyurethanes as listed above.Furthermore, bioremodelable materials may also be used singly or incombination with the aforementioned polymer materials. The textile maybe made of one or more polymers that do not require treatment ormodification to be biocompatible. The graft may be constructed fromwoven multifilament polyester, for example and without limitation,Dacron™, produced by DuPONT. Dacron™ is known to be sufficientlybiologically inert, non-biodegradable, and durable to permit safeinsertion inside the human body.

The term “prosthesis” means any device for insertion or implantationinto or replacement for a body part or function of that body part. Itmay also mean a device that enhances or adds functionality to aphysiological system. The term prosthesis may include, for example andwithout limitation, a stent, stent-graft, filter, valve, balloon,embolization coil, and the like.

The term “tubular” refers to the general shape of an endoluminal devicewhich allows the module to carry fluid along a distance or fit within atubular structure such as an artery. Tubular prosthetic devices includesingle, branched, and bifurcated devices. Tubular may refer to any shapeincluding, but not limited to, tapered, cylindrical, curvilinear, or anycombination thereof. A tubular device may have a cross-sectional shapethat is, circular, substantially circular or the like. However, itshould be understood that the cross-sectional shape is not limitedthereto, and other shapes, such as, for example, hexagonal, pentagonal,octagonal, or the like are contemplated. The term “endoluminal” refersto or describes objects that can be placed inside a lumen or a bodypassageway in a human or animal body. A lumen or a body passageway canbe an existing lumen or a lumen created by surgical intervention. Asused in this specification, the terms “lumen” or “body passageway” areintended to have a broad meaning and encompasses any duct (e.g., naturalor iatrogenic) within the human body and can include a member selectedfrom the group comprising: blood vessels, respiratory ducts,gastrointestinal ducts, and the like. “Endoluminal device” or“endoluminal prosthesis” thus describes devices that can be placedinside one of these lumens.

The term “graft” or “graft material” describes an object, device, orstructure that is joined to or that is capable of being joined to orimplanted in or against a body part to enhance, repair, or replace aportion or a function of that body part. A graft by itself or with theaddition of other elements, such as structural components, may comprisean endoluminal prosthesis. The graft may be comprised of a singlematerial, a blend of materials, a weave, a laminate, or a composite oftwo or more materials. The graft may be constructed from natural ororganic materials, for example and without limitation, a biologicalscaffold or bioremodelable material, such as small intestine submucosa(“SIS”), which is commercially available by Cook Biotech, WestLafayette, Ind. The graft may also be constructed from a synthetic, forexample and without limitation, a polymer. The graft may be formed froma single layer or multiple layers of material. In embodiments employinga plurality of layers of material, the layers may remain separate, ormay be attached to each other through a secondary process such assintering, curing, adhesives, and sutures or the like.

The term “stent” means any device or structure that adds rigidity,expansion force or support to a prosthesis. A stent is used to obtainand maintain the patency of the body passageway while maintaining theintegrity of the passageway. Also, the stent may be used to form a seal.The stent may be located on the exterior of the device, the interior ofthe device, or both. A stent may be self-expanding, balloon-expandableor may have characteristics of both. A variety of other stentconfigurations are also contemplated by the use of the term “stent.” Thestents 16 may be comprised of a metallic material selected fromstainless steel, silver, platinum, palladium, gold, titanium, tantalum,iridium, tungsten, cobalt, chromium, cobalt-chromium alloy 1058,cobalt-based 35N alloy, nickel-based alloy 625, a molybdenum alloy, amolybdenum alloy including about 0.4% to about 0.8% of lanthanum oxide(Li₂O₃), and a nickel-titanium alloy, such as nitinol, or other suitablematerials as known in the art. The stents may be made of a wire, or maybe laser or cannula cut, or manufactured by other known methods.

The term “yarn” refers to a length of a continuous thread or strand ofone or more filaments or fibers, with or without twist, suitable forweaving, knitting or otherwise intertwining to form a textile fabric.

The term “branch vessel” refers to a vessel that branches off from amain vessel. Examples are the celiac and renal arteries which are branchvessels to the aorta (i.e., the main vessel in this context). As anotherexample, the hypogastric artery is a branch vessel to the common iliac,which is a main vessel in this context. Thus, it should be seen that“branch vessel” and “main vessel” are relative terms.

“Longitudinally” refers to a direction, position or length substantiallyparallel with a longitudinal axis of a reference, and is the length-wisecomponent of the helical orientation.

“Circumferentially” refers to a direction, position, or length thatencircles a longitudinal axis of reference. The term “circumferential”is not restricted to a full 360° circumferential turn or to a constantradius.

The terms “patient,” “subject,” and “recipient” as used in thisapplication refer to any animal, especially humans.

FIGS. 1-8 show a fenestrated prosthesis 10, here a stent graft, having atubular body and comprising a biocompatible material, having one or morefenestrations 12 pivotable in any direction away from an axisperpendicular to a longitudinal axis of the prosthesis. The pivotablefenestrations 12 have a diameter extending from a sidewall of the graft.The pivotable fenestrations 12 include a first, inner perimeter 26surrounding the fenestration 12 having a diameter, a band 28 of flexiblematerial attached to and surrounding the first perimeter 26, and asecond, outer perimeter 30 attached to and surrounding the band 28 offlexible material. The band 28 of material has a first diameter that issubstantially the same as the diameter of the first perimeter 26, and asecond diameter substantially the same as the second perimeter 30. Thediameter of the band of material decreases in a direction away from thesurface 20 of the graft 14 from the second perimeter to the firstperimeter. The band of flexible material may include a flexible frame48.

In some aspects, the fenestrated prosthesis 10 is intended for placementin the abdominal aorta and to accommodate vessels that branch from theaorta, for example, the renal arteries, and into which a branch vesselprosthesis may be placed. However, the fenestrated prosthesis 10 is notlimited for use in the abdominal aorta but may be used in other vesselsof the body from which other vessels branch, such as the ascendingthoracic aorta, the descending thoracic aorta, as well as other bodyvessels.

FIG. 1 shows a perspective view of a prosthesis 10 that is a stentgraft. The prosthesis 10 includes graft material 14 associated with oneor more stents 16. The prosthesis 10 has a proximal end 22, a distal end24, and a lumen 18 extending through the prosthesis 10 to permit passageof blood flow from the proximal end 22 to the distal end 24. The stents16 may be placed on the external surface 20 and/or internal surface 21of the graft material 14. In one particular embodiment, the prosthesis10, such as that shown in FIG. 1, has external body stents 16 a, 16 b,and 16 c, and at least one internal stent 16 d. The internal stent 16 dmay be a sealing stent and placed at or near the proximal end 22 of theprosthesis 10 to seal the prosthesis 10 at the proximal end 22 to thewalls of a blood vessel into which it has been placed. Additionally, oralternatively, depending on the location of the place of the prosthesis10 or a particular need, a sealing stent 16 d may be placed at either orboth the proximal and distal ends 22, 24 of prosthesis 10. Theprosthesis 10 also may include an attachment mechanism, for example, anattachment stent 42, at either or both ends of the prosthesis 10, tofurther secure the prosthesis 10 within the body vessel and preventmigration of the prosthesis 10.

As shown in FIG. 1, the prosthesis 10 has several openings orfenestrations that extend from the internal surface 21 to the externalsurface 20 of the graft material 14. The prosthesis 10 of FIG. 1 has twopivotable fenestrations 12, at least one non-pivotable fenestration 38,and a scallop 40. Here, the scallop 40 is placed at the proximal end ofthe prosthesis 10.

FIGS. 1-8 show various aspects and views of the prosthesis 10 havingpivotable fenestrations 12. Pivotable fenestrations 12 have an innerperimeter 26 surrounding the fenestration 12, a band 28 surrounding theinner perimeter 26, and an outer perimeter 30 surrounding the band 28.As shown, the outer perimeter 30 diameter is greater than the band 28diameter and the inner perimeter diameter 26. The inner perimeter 26,the band 28 and the outer perimeter 30 would be substantially concentricwith one another if they were in the same plane, for example the surfaceplane of the graft. The inner perimeter 26, the band 28 and the outerperimeter 30 may form a hemispherical shape, resembling a dome, or afrustoconical cone extending from the surface of the graft material 14.The fenestration 12 is provided at the peak or top of the hemisphericalshape or extension. In other embodiments, the band 28 may comprise atapered, flexible tube extending from the outer perimeter 30 and theinner diameter 26.

Stents 16, for example those shown in the Figures may be, for examplezig zag stents, also known has Z-stents, that comprise a series ofstruts 32, 34 connected by apices 36, although the type of stent used isnot so limited. When Z-stents are used, a portion of the outer perimeter30 of one or more of the fenestrations 12 may lie between adjacentstruts 32, 34 of one of the stents 16. The stents 16 may be eitherself-expanding or balloon expandable. Preferably, they areself-expanding. However, a combination of self-expanding and balloonexpandable stents also may be contemplated.

As set forth above, the stents 16 include struts 32, 34 that are spacedapart from each other. The strut spacing is measured from bend-to-bend(or apex to apex 36). Stent amplitude, spacing and stagger arepreferably optimized for each prosthesis design. In some aspects, theapices or bends 36 of the struts 32, 34 may be staggered for minimalcontact with each other. As shown in FIG. 1, the stents 16 a, 16 b, 16 care positioned adjacent each other and the apices 36 of each row are incircumferential alignment with the bends of longitudinally adjacentrows. In other aspects, as shown in FIG. 5, every bend 36 of each rowmay be in substantial circumferential alignment with the bends 36 oflongitudinally adjacent rows.

The pivotable fenestrations 12 may be located within the lumen 18 of theprosthesis 10 or extending from the exterior of the prosthesis 10. Inthe first aspect, the pivotable fenestrations 12 may be said to beconcave, relative to the external surface 20 of the graft material 14.In the second aspect, the pivotable fenestrations 12 may be said to beconvex, relative to the external surface 20 of the graft material 14.FIG. 1 shows the pivotable fenestrations 12 located internal to theprosthesis 10, that is, they lie within the lumen 18 of the prosthesis10. In the particular aspect shown in FIG. 1, the pivotablefenestrations 12 reside substantially on one side of the prosthesis 10and are adjacent to one another. In the aspects shown in FIGS. 3-4 and7-8, the pivotable fenestrations 12 are positioned to align with, forexample, the renal arteries. In other aspects, the one or more pivotablefenestrations 12 may be positioned to align with other branch arteriesthroughout a diseased vasculature. Additional fenestrations and scallopsas disclosed here may also be included.

FIG. 2, which is a partial internal view of the prosthesis 10 of FIG. 1,shows a view of the prosthesis 10 looking into the lumen 18 of theprosthesis 10 from the proximal end 22. As shown, pivotablefenestrations 12 extend or protrude into the lumen 18. Pivotablefenestrations 12 have an inner perimeter 26, a band 28, and an outerperimeter 30. As shown in FIG. 2, the outer perimeter 30 liessubstantially flush (in the same plane) of the graft material 14, andthe band 28 and the outer perimeter 30 form a hemispherical shape, suchas a dome or frustoconical cone extending into the lumen 18. Althoughboth the first and outer perimeters 26, 30 are shown as substantiallycircular, they may be oval, oblong or some other desired geometricshape.

FIGS. 3 and 4 show an aspect of a prosthesis 10 having externallyextending pivotable fenestrations 12. FIG. 3 shows a partial view of aprosthesis 10 having two externally extending pivotable fenestrations 12extending form opposite sides of the prosthesis 10. As with the otheraspects, the fenestrations 12 have an inner perimeter 26 surrounding thefenestration, a band 28 of material surrounding the inner perimeter 26,and an outer perimeter 30 surrounding the band 28 of material. FIG. 4,which is a partial internal view of the prosthesis 10 of FIG. 3, shows aview of the prosthesis 10 of FIG. 3, looking into the lumen 18 of theprosthesis 10 from the proximal end 22. As shown, pivotablefenestrations 12 extent or protrude away from the external surface 20 ofthe graft material 14. The outer perimeter 30 lies substantially flush(in the same plane) of the graft material 14, and the band 28 and theouter perimeter 30 form a hemispherical shape, such as a dome, orfrustoconical cone extending into the lumen 18.

FIGS. 5 and 6 show further aspects of a fenestrated prosthesis 10 havingat least one pivotable fenestration 12. FIG. 5 shows a prosthesis 10that is a stent graft. The prosthesis includes that has a proximal end22, a distal end 24, a graft material 14 associated with a series ofexternal stents 16. The prosthesis 10 further has an internal sealingstent 16 d, and attachment stent 42, and a pivotable fenestration 12.FIG. 6 shows a partial close up view of the fenestration of FIG. 5. Thepivotable fenestration 12 shown is an external fenestration 12 and hasan inner perimeter 26 surrounding the fenestration 12, a band 28 ofmaterial surrounding the inner perimeter 26, and an outer perimeter 30surrounding the band 26. As shown, a portion of the outer perimeter 30lies between struts 32, 34 of the proximal most stent 16. Referring backto FIG. 5, the prosthesis 10 includes a non-pivoting fenestration 28 anda scallop 40 at the proximal end 22. As shown in these Figures andthroughout the Figures, imageable markers 35, which may be viewed duringand after placement of the prosthesis 10 may be placed at variouslocations on the prosthesis 10 to identify certain aspects of theprosthesis and their location during the implantation procedure andfacilitate correct placement of the fenestrations 12, 38, scallop 40,the ends of the prosthesis and the like. For example, as shown in FIG.6, markers 35 may be placed about the circumference of the outerperimeter 30. The markers 35 may be, for example, sewn or sutured to thegraft material 14, as shown, or may be woven into the graft (not shown).The markers 35 also may be placed on the struts of one or more stents,for example, radiopaque marker tubes may be placed about one or morestruts of the stent to indicate various areas of the stent graft. Asshown, the markers 35 may be gold, however, any material that may beimaged by way of angiography, fluoroscopy, 3D imaging, MRI, or the like,may be suitable.

As further shown, particularly in FIGS. 6-7, the fenestrations 12, 38and the scallop 40 may include a reinforcement frame 44 a, 44 b, 44 c,44 d which may be sutured or otherwise attached to the graft 14. Forexample, in FIGS. 6-7, a reinforcement frame 44 a may be positionedabout the outer perimeter 30. As shown in FIG. 6, a reinforcement frame44 b may be positioned about the inner perimeter 26. As shown in FIG. 7,in particular, a reinforcement frame 44 c may be provided about thenon-pivoting fenestration 38, and reinforcement frame 44 d may beprovided about the perimeter of the scallop 40. The reinforcement frames44 a, 44 b, 44 c, 44 d may be rings. In one preferred aspect, thereinforcement frames 44 a, 44 b, 44 c, 44 d are a wire that is suturedabout the fenestration 12, 38, or scallop 40, to reinforce thefenestration or scallop. The reinforcement frames 44 a, 44 b, 44 c, 44 dmay be made of any suitable material. One preferred material is asuperelastic or shape memory material, such as nitinol. In anotherpreferred embodiment, the reinforcement frames 44 a, 44 b, 44 c, 44 dmay be made of radiopaque or other imageable material. In anotherembodiment the reinforcement frames 44 a, 44 b, 44 c, 44 d may be solidrings, or may be a wire that is looped about itself into a ring withunattached ends such that the ring may be expanded or contracted indiameter. Suitable frames are disclosed in U.S. patent application Ser.No. 10/962,632, filed Oct. 12, 2004, hereby incorporated by reference.

FIG. 8 is another partial and internal view of a fenestrated prosthesis10 having two internal pivotable fenestrations 12. As shown in thisaspect, a dome-like projection or frustoconical extension is formedwithin the prosthesis 10. A flexible frame 48 may be disposed about orwithin the band 28.

As shown throughout the Figures, inner perimeter 26, band 28, and outerperimeter 30 surround the pivotable fenestration 12 to create ahemisphere shaped or frustoconical extension or protrusion. The outerperimeter 30 may be affixed to the graft material 14 by any attachmentmethod including suturing circumferentially about an aperture disposedthrough graft material 14. The band 28 may be comprised of the same ordifferent biocompatible material as the graft material 14. For example,the second biocompatible material may have greater pliability than thefirst biocompatible graft material used for the tubular graft body.

The band 28 is sufficiently flexible to permit the fenestration 12 tomove such that a branch stent disposed in the fenestration 12 may beoriented upwardly, downwardly, laterally, diagonally and the like. Insome aspects, the band has up to about 180 degrees of freedom ofmovement relative to the surface plane of the prosthesis 10.Accordingly, the pivotable fenestration 12 allows the prosthesis 10 tobe used with a variety of patients, due to its ability to adapt to thevariance in the positioning of the diseased branch vessels. For example,if a body branch vessel is or becomes offset longitudinally or axiallyfrom a pivoting fenestration 12, the pivoting fenestration 12 will pivotthe branch vessel prosthesis in the necessary direction and to thenecessary degree to maintain the branch vessel prosthesis in place inthe branch vessel.

FIG. 9 shows a partial, cross-sectional view of a portion of prosthesis10 having a pivotable fenestration 12, inner perimeter 26 surroundingfenestration 12, band 28 surrounding inner perimeter 26 and outerperimeter surrounding band 28. The band 28 may be tapered such that thediameter decreases throughout its depth γ. The depth γ may be determinedon the amount of movement required for the pivotable fenestration 12during use and the ability to cannulate the targeted branch vessel. Asthe depth γ the amount of second biocompatible material used for theband 28 must also decrease, which limits the range of motion of thepivotable fenestration 12. Furthermore, the depth γ must be large enoughin order to cannulate the targeted branch vessel. The depth γ may rangefrom 3 to 10 mm, and preferably is about 6 mm. As shown, inner perimeter26 has a diameter α that is smaller than the diameter β of outerperimeter 30. The diameter α inner perimeter 28 may be determined basedon the average size of the targeted branch vessel. In this aspect, theprosthesis 10 may be used to repair a diseased renal artery.Accordingly, the average diameter of the inner perimeter 26 may be basedon the average of the diameter α of the openings to the renal arteries,or about 6 mm.

The diameter β of the outer perimeter 30 may be determined based on thedesired amount of movement and the desired patency of the prosthesis 10.As the diameter β of the outer perimeter 30 changes, the range of motionalso changes. As the diameter β of the outer perimeter 30 decreases, therange of motion also decreases. Additionally, the diameter β of theouter perimeter 30 must be sized to prevent interference withcircumferentially adjacent struts 32, 34 of the stents 16. Hence, thediameter β of the outer perimeter 30 may be at most about 15 mm in orderto accommodate stents 16. The diameters α and β combined with depth γprovide the requisite amount of surface area for band 28 for thepivotable fenestration 12 to pivot during deployment of a secondarybranch prosthesis into the fenestration 12 of after deployment based ondynamic changes to the anatomy.

FIGS. 10 and 11 show an internal view and an external view,respectively, of a pivotable fenestration 12 in an aspect where thefenestration is disposed within the lumen 18 of the prosthesis 10. FIG.10 shows pivotable fenestration 12, inner perimeter 26, band 28, outerperimeter 30. The inner perimeter 26 and outer perimeter 28 areinforcement frame 44 a is positioned about the outer perimeter 30. Areinforcement frame 44 b is positioned about the inner perimeter 26. Asdiscussed above, the reinforcement frames 44 a and 44 b may be affixedto the 26 outer perimeter 30 and inner perimeter 26 may be, for example,sewn to the outer surface 20 of the graft material 14. Markers 35 areplaced around the inner perimeter 26 in order to facilitate properplacement and alignment of a branch vessel prosthesis and the pivotablefenestration 12.

As shown in FIG. 10, the band 28 may be provided with a flexible frame48. The flexible frame 48 provides support to the band 28 and helps tomaintain the overall structure of the band 28 upon deployment within thediseased vessel. The flexible frame 48 also helps to maintain thepatency of the pivotable fenestration 12. The flexible frame 48 allowsto the band of material to reverse orientation and independently movebetween an interior surface of the prosthesis 10 and an exterior surfaceof the prosthesis 10 while the device is being deployed. In someembodiments, a physician may alter the orientation of the band 28 duringdeployment of the prosthesis 10 through the use of endoluminal devices,such as a guidewire catheter. The structure of the flexible frame 48also prevents the pivotable fenestration 12 from everting or inverting(depending on the initial configuration) once the prosthesis 10 isdeployed within the diseased vessel. The flexible frame 48 may bepositioned on the band 28 either on the interior or exterior surface ofthe band 28. In this particular aspect, the flexible frame 48 isposition on the interior surface of the band 28. The flexible frame 48comprises a continuous wire formed into a plurality of support units 50having a generally undulating shape comprising straightened struts 52interconnected by outwardly facing apices or bends 54. The number ofsupport units 50 may range from about 2 support units to about 10support units.

In a preferred aspect, the flexible frame 48 has three support units 50.For example, as shown in FIG. 10, the outwardly facing apices 54 mayabut or connect to the reinforcing frame 44 a of the outer perimeter 30.The outwardly facing apices may be, for example, sewn or sutured toreinforcing frame 44 a. The frame 48 may be bent to form a plurality ofloops 56 a, 56 b, 56 c, 56 d. Loops 56 a, 56 b, 56 c are positioned inthe troughs of the apices 52 of adjacent support units 50. Each loop 56a, 56 b, 56 c may abut or connect to the reinforcing frame 44 b of theinner perimeter 26. The loops 56 a, 56 b, 56 c may be, for example, sewnor sutured to reinforcing frame 44 b. A loop 56 d may be positionedwithin an apex 54 of a support unit 50. Other aspects may comprise otherconfigurations for the flexible frame 48, including, but not limited to,spirals, may be suitable. The flexible frame 48 may be heat set into thedesired configuration prior to attachment to band 28. The flexible frame48 may be comprised of an elastic or super elastic material, for exampleand without limitation, nitinol.

FIG. 11 shows an exterior view of a pivotable fenestration 12 where thefenestration is disposed within the lumen of the prosthesis. Thepivotable fenestration 12 has an inner perimeter 26 surrounding thefenestration 12, a band 28 surrounding the inner perimeter 26, and anouter perimeter 30 surrounding the band 28. The inner perimeter 26 andouter perimeter 28 a reinforcement frame 44 a is positioned about theouter perimeter 30. Markers 37 may be sewn to around the circumferenceof the outer perimeter 30 in order to facilitate proper placement andalignment of the pivotable fenestration 12 and the targeted branchvessel.

FIG. 12 shows an embodiment of the band 28 formed from a protrusion 58having a bubble like configuration as shown in FIG. 12, as described inco-pending U.S. patent application Ser. No. 12/548,120. The protrusion58 is integrally formed with the body of the prosthesis 10 and iscomprised of a second biocompatible graft material. The protrusion 58may be created during the weaving process used to create the graftmaterial 14. The prosthesis 10 may include, but is not limited to,weaves such as plain weaves, basket weaves, rep or rib weaves, twillweaves (e.g., straight twill, reverse twill, herringbone twill), satinweaves, and double weaves (e.g., double-width, tubular double weave,reversed double weave). Desirably, the weave comprises a tubular doublelayer weave. The fabric may be woven on a table loom, a floor loom, ajacquard loom, a counterbalance loom, a jack loom, or an upright loom.Desirably, the fabric is woven on a floor loom. The fabric may have anyconfiguration possible, but preferably has warp and weft yarns. In oneaspect, both the warp yarns and the weft yarns are textile yarns.

In order to create the protrusion 58, the number of warp yarns usedwhile weaving the prosthesis 10 is increased in the region where theprotrusion 315 is desired. While the additional warp yarns are weavedinto the prosthesis 310, the number of weft yarns is kept constant. Byincreasing the number of warp yarns while holding the number of weftyarns constant, the second biocompatible graft material expandsoutwardly in the radial direction. The number of warp yarns is increaseduntil a pre-determined diameter has been reached. Once the desired depthfor the protrusion 58 is reached, the number of warp yarns introducedinto the weaving apparatus is decreased until the number of warp yarnsis equal to the number of weft yarns used to form the remainder of theprosthesis 10. A fenestration may be created through the protrusion 58by applying heat to the center of the protrusion 10. Reinforcing framesmay be added about the fenestration and adjacent to and surrounding theprotrusion 58 to form the inner and outer perimeters 26, 30 of theprosthesis 10. Further, a flexible frame 48 may be attached to theprotrusion 58 to maintain it in its desired extended configuration.

FIG. 13 depicts an exemplary prosthesis that has been deployed within adiseased vessel 70, such as the aorta. The prosthesis 10 comprises atubular graft 72 having a sidewall 74 and a lumen 76 disposedlongitudinally therein. The prosthesis 10 includes a first end 78 and asecond end 80. The tubular graft 72 includes a plurality of rows 82 a,82 b, 82 c of expandable stents circumferentially aligned affixed to theouter surface 84 of the tubular graft 72. A sealing stent 86 may beaffixed to the first end 78 of the tubular graft 72 within the interiorsurface of the graft 72. The sealing stent 86 may be attached to thefirst end 78 of the tubular graft 72 by any attaching mechanism, forexample and without limitation, suturing. Radiopaque markers 88 may beplaced on the tubular graft 72 in order to assist with proper alignmentof the tubular graft 72 when deployed within a patient. Fenestrations 90may be disposed through the tubular graft 72. The distal end (not shown)of the prosthesis 10 may be bifurcated.

The tubular graft 72 also includes two internal pivotable fenestrations12 that are in communication with the lumen 76. The tubular graft 72 maybe preloaded onto a delivery device for deployment within a patient. Thedelivery device includes a sheath over the tubular graft 72 to keep thetubular graft 72 in a compressed state prior to deployment. The deliverydevice is placed over a guide wire and after checking the appearance andorientation of the device under x-ray, guide wires for each fenestration12 are loaded through side ports in the handle of the delivery device.The delivery device is introduced over the guide wire, and advanceduntil a tapered tip of the delivery device is in the femoral artery andthe radiopaque markers indicating the fenestrations 12 are at a level ofthe appropriate arteries. A sheath is advanced over the guide wire foreach fenestration 12 through each side port on the handle of the device.Once the sheaths for the fenestrations 12 are in position, the tubulargraft 72 can be advanced to its correct position and orientation fordeployment. The tubular graft 72 is deployed by withdrawing the sheathcovering the graft over the pusher. The operator can perform angiographyand adjust the placement of the tubular graft 72 if necessary.Deployment is continued until the tubular graft 72 is fully unsheathed.The sheaths for the fenestrations 12 are advanced over the wires untilthey are at a level of the lower margin of the fenestration 12. Thesheaths for the fenestrations 12 are punctured and a guide wire isadvanced through each sheath. A catheter is advanced over the guidewires, and once the catheters are in the target vessels, a stiffer wirereplaces the guide wire. The sheaths for the fenestrations 12 are thenadvanced into the target vessels and branch vessel prostheses areadvanced through the sheath and placed in the desired position.

FIG. 13 illustrates in accordance with the procedure described abovebranch vessel prosthesis deployed through each of the two fenestrations12. Branch vessel prostheses 92, 94 are formed from biocompatiblematerials and may comprise covered stents. Alternatively, they maycomprise bare stents. The covered or bare stents may be eitherself-expanding or balloon expandable. In one aspect the branch vesselstent may have both self expanding and balloon expandable components.For example, the branch vessel stent may have an end not shown forplacement within the fenestration this is upon deployment, eitherself-expanding or by balloon expansion. If the branch vessel stent is acovered stent, the graft material used may comprise one or more of thebiocompatible materials are discussed above.

As shown in FIG. 13, the branch vessel prostheses 92, 94 are deployedinto branch vessels 96, 98 such as the right and left renal arteries. Asshown in Figure, the right opening 100 is not completely aligned withthe right branch vessel 92. Particularly, the right branch vessel 96 ispositioned lower than the corresponding left branch vessel 98. Toaccommodate placement of the branch vessel prosthesis 92 into the rightbranch vessel 96, the pivotable fenestration 12 provides the requisiteflexibility and ability to pivot required for the branch vesselprosthesis 92 to deploy into the desired position.

FIGS. 14 and 15 show a branch vessel prosthesis 92 deployed in asecondary branch vessel in greater detail. As shown in FIG. 14, thebranch vessel prosthesis 92 is deployed within the right branch vessel96, which is positioned lower than its corresponding left branch vessel.Alternatively, as shown in FIG. 15, the branch vessel prosthesis 92 isdeployed within the right branch vessel 102, which is positioned higherthan its corresponding left branch vessel. The pivotable fenestration 12allows for pivoting motion to accommodate the offset position of theright branch vessel 98, 102 and provide access to the right branchvessel 96, 102 through the use of a delivery device, such as a catheter.

Once a catheter is placed within right branch vessel 96, 102, the branchvessel prosthesis 92 may be deployed within the right branch vessel 96,102. The branch vessel prosthesis 92 may be balloon expandable orself-expandable. In this aspect, the branch vessel prosthesis 92 isballoon expandable. Once the secondary branch prosthesis 146 is deployedin the right branch vessel 96, 102, the end of the branch vesselprosthesis 92 remaining within the interior surface of the prosthesis 10may be flared in order to provide a proper seal between the fenestration12 and the branch vessel 96, 102.

Referring now to FIGS. 16-19, an alternative endoluminal prosthesis 200is shown and described. The prosthesis 200 comprises a graft 214 havinga tubular body comprising proximal and distal ends 222 and 224, and alumen 218 extending therebetween.

The prosthesis 200 comprises a valve replacement 260 disposed betweenthe proximal end 222 and the distal end 224 of the graft 214. In oneexample, the artificial valve 260 can be coupled to the graft 214 withsuture.

In one non-limiting example, the valve replacement may comprise anaortic valve designed to replace the function of the recipient's nativedamaged or poorly performing aortic valve. In other examples, theprosthesis 200 may be deployed in other arterial locations, i.e., otherthan the aortic sinus and ascending aorta, or alternatively may bedeployed in a patient's venous system, or any suitable duct, passagewayor vessel.

In the non-limiting example of an aortic valve, the artificial valve 260may be located at the proximal end 222 of the graft 214, closest to theheart. The artificial valve 260 preferably includes one or more leaflets262, as shown in FIGS. 17A-17B. In this non-limiting example, theartificial valve 260 includes three leaflets 262, though only twoleaflets may be used in a “bicuspid” arrangement. The leaflets arearranged in the prosthesis such that the leaflets mimic a naturallyoccurring aortic valve. The artificial valve 260 “opens” to allow bloodflow when the pressure on the proximal side of the artificial valve 260is greater than pressure on the distal side of the artificial valve.Thus, the artificial valve 260 regulates the unidirectional flow offluid from the heart into the aorta.

The leaflets of the artificial valve 260 can be fabricated from any atleast substantially biocompatible material including such materials aspolyester fabrics, polytetrafluoroethylene (PTFE), expanded PTFE, andother synthetic materials known to those of skill in the art.Preferably, the leaflets are fabricated from naturally occurringbiomaterials. The leaflets can include a derived collagen material, suchas an extracellular matrix. The extracellular matrix can be smallintestinal submucosa, stomach submucosa, pericardium, liver basementmembrane, urinary bladder submucosa, tissue mucosa, dura mater, or thelike.

The prosthesis 200 further comprises at least one stent coupled to thegraft 214 that has a contracted delivery state and further has anexpanded state for maintaining patency within a portion of the graft. Inthe exemplary embodiment depicted in FIGS. 16 and 20, five exemplarystents 216 a-216 e are provided. As described with respect to the stents16 above, the stents 216 may be placed on the external surface and/orinternal surface of the graft 214. Like the stents 16 described above,the exemplary stents 216 of the prosthesis 200 comprise zig zag stents,and may be either self-expanding or balloon expandable.

In the embodiment of FIG. 16, a first stent 216 a is located at theproximal end of the graft 214. In use, the first stent 216 a overlapswith an aortic annulus 297, as shown in FIG. 20. The first stent maycomprise a radial force configured to facilitate fixation within theaortic annulus 297 and prevent migration of the proximal end 222 of thegraft 214. One or more barbs 225 may be coupled to the first stent 216 ato reduce migration of the prosthesis 200.

In the example of FIG. 16, the endoluminal prosthesis 200 comprisessecond and third z-stents 216 b and 216 c, which are coupled to thegraft 214 such that the distal apices of the second stent 216 b arealigned with the proximal apices of the third stent 216 c. At least onefenestration 212 is positioned between a proximal apex of the secondstent 216 b and a distal apex of the third stent 216 c. The fifth stent216 e may be configured to engage a healthy portion of a patient'sascending aorta 298, as depicted in the deployed state of FIG. 20.

The endoluminal prosthesis 200 further comprises at least onefenestration 212 disposed in a sidewall 274 of the graft 214. In theembodiment of FIGS. 16-20, first and second fenestrations 212 a and 212b are disposed in the sidewall 274 at locations distal to the valvereplacement 260, as seen in the top view of FIG. 17A.

The first and second fenestrations 212 a and 212 b preferably areprovided in accordance with the fenestrations 12 described in detailabove. Accordingly, at least one of the fenestrations 212 a and 212 b,and preferably each fenestration, is pivotable in any direction awayfrom an axis perpendicular to a longitudinal axis of the prosthesis.Each of the fenestrations 212 a and 212 b may comprise the firstperimeter, the band of flexible material, and the second perimeterdescribed in detail above. As described above, the band of material ofthe fenestrations 212 a and 212 b may have a concave or convexorientation relative to the surface of the graft 214. Further, the bandof material may be configured to independently move between an interiorsurface of the graft 214 and an exterior surface of the graft 214.

In the non-limiting example of FIGS. 16-20, the first and secondfenestrations are disposed in graft 214 at locations between about 90and about 270 degrees apart, though the positioning may be greater orless. In the deployed state, a first branch vessel prosthesis 292 aextends between the first fenestration 212 a and a first coronary artery295 a in a deployed state, and a second branch vessel prosthesis 292 bextends between the second fenestration 212 b and a second coronaryartery 295 b, as depicted in FIG. 20. The branch vessel prostheses 292 aand 292 b may be provided in accordance with the branch vesselprostheses 92 and 94 of FIG. 13 above. Moreover, delivery and deploymentof the graft 214, and the branch vessel prostheses 292 a and 292 b, maybe provided in accordance with delivery and deployment of the graft 14and the branch vessel prostheses 92 and 94, as outlined with respect toFIG. 13 above.

In the embodiment of FIGS. 16-20, the branch vessel prostheses 292 a and292 b are deployed into the right and left coronary arteries 292 a and292 b. Advantageously, if the first and second fenestrations 212 a and212 b are not exactly aligned with the coronary arteries for any reason,such as variable patient anatomy, then the pivotable fenestrations 212 aand 212 b provide the requisite flexibility and ability to pivot so thatthe branch vessel prostheses 292 and 294 to deploy into the desiredposition.

In the examples of FIGS. 16-20, the deployment of the prosthesis 200into the state shown in FIG. 20 may be achieved in different manners. Inone example, the deployment may be made using a transapical ortranseptal approach, in which case the prosthesis 200 may be secured toan exemplary delivery system 270 as shown in FIG. 18. In the transapicalor transeptal approach, an atraumatic tip 272 of the delivery system isadvanced in an antegrade fashion, i.e., in a direction from the aorticannulus 297 towards the ascending aorta 298.

In another example, the deployment may be made using a femoral, carotid,subclavian or axiliary approach, in which case the prosthesis 200 may besecured to the exemplary delivery system 270 as shown in FIG. 19. Inthis approach, the atraumatic tip 272 of the delivery system 270 isadvanced in a retrograde fashion, i.e., in a direction from theascending aorta 298 towards the aortic annulus 297. In either deliveryapproach, as shown in FIGS. 18-19, the graft 214 may comprise one ormore regions 213 that are radially restrained.

Further, the prosthesis 200 may be provided as part of a preloadedsystem that includes a guide wire 275. In this example, a first endsegment 276 of the guide wire 276 may enter the lumen 218 through aproximal or distal end of the prosthesis 200, depending on the deliveryorientation of the prosthesis shown in FIG. 18 as compared to FIG. 19.The first end segment 276 exits the graft 214 through the firstfenestration 212 a. An intermediate segment of the guide wire 275 mayextend external of the graft 214 and reenter the lumen 218 of theprosthesis 200 through the second fenestration 212 b. A second endsegment 277 of the guide wire 275 may extend distally within the lumen218 and may extend distally to the distal end of the delivery device270. The first end segment 276 of the guide wire 275 may enableintroduction of the first branch prosthesis 292 a into the firstfenestration 212 a to couple the prosthesis 200 to the right coronaryartery, and the second end segment 277 of the guide wire 277 may enableintroduction of the second branch prosthesis 292 b into the secondfenestration 2212 b to couple the prosthesis to the left coronaryartery.

Further details of a such preloaded wire, and how it may facilitatedeployment of stent-grafts into branch vessels, are described in furtherdetail in U.S. Provisional Patent Application Ser. No. 61/579,027, whichis hereby incorporated by reference in its entirety. While one exemplarydelivery system has been shown, it will be appreciated that a number ofdelivery systems and techniques may be used to deploy the prosthesis200.

As noted above, while one exemplary use of the prosthesis 200 has beenshown with regard to the aortic sinus and ascending aorta, theprosthesis 200 alternatively may be deployed in other parts of apatient's arterial or venous system, or any suitable duct, passageway orvessel.

While various embodiments of the invention have been described, theinvention is not to be restricted except in light of the attached claimsand their equivalents. Moreover, the advantages described herein are notnecessarily the only advantages of the invention and it is notnecessarily expected that every embodiment of the invention will achieveall of the advantages described.

I claim:
 1. An endoluminal prosthesis comprising: a graft having atubular body comprising proximal and distal ends; a valve replacementdisposed between the proximal and distal ends of the graft; at least onestent coupled to the graft, the at least one stent having a contracteddelivery state and an expanded state for maintaining patency within aportion of the graft; at least one fenestration disposed in a sidewallof the graft at a location distal to the valve replacement; a firstperimeter having a first diameter and surrounding the at least onefenestration; a band of flexible material attached to and surroundingthe first perimeter and having a flexible frame; and a second perimeterattached to and surrounding the band of flexible material and having asecond diameter greater than the first perimeter diameter; where theband of material has a first diameter substantially the same as thefirst perimeter diameter and a second diameter substantially the same asthe diameter of the second perimeter, and where the diameter of the bandof material decreases in a direction away from the surface of the graftfrom the second perimeter to the first perimeter, wherein the band ofmaterial is configured to independently move between an interior surfaceof the graft and an exterior surface of the graft, and wherein theflexible frame extends about a surface of the band from the firstperimeter to the second perimeter.
 2. The endoluminal prosthesis ofclaim 1 wherein the at least one fenestration is pivotable in anydirection away from an axis perpendicular to a longitudinal axis of theprosthesis.
 3. The endoluminal prosthesis of claim 1 wherein the band ofmaterial has a concave or convex orientation relative to the surface ofthe graft.
 4. The endoluminal prosthesis of claim 1 wherein first andsecond fenestrations are disposed in the graft at locations betweenabout 90 and about 270 degrees apart.
 5. The endoluminal prosthesis ofclaim 4 further comprising a first branch vessel prosthesis extendingbetween the first fenestration and a right coronary artery in a deployedstate, and a second branch vessel prosthesis extending between thesecond fenestration and a left coronary artery in the deployed state. 6.The endoluminal prosthesis of claim 1 wherein first and second z-stentsare coupled to the graft such that the distal apices of the first stentare aligned with the proximal apices of the second stent, and the atleast one fenestration is positioned between a proximal apex of thefirst stent and a distal apex of the second stent.
 7. The endoluminalprosthesis of claim 1 wherein the valve replacement comprises anartificial valve having a tricuspid shape.
 8. The endoluminal prosthesisof claim 1 wherein the valve replacement is located at the proximal endof the graft, and one or more barbs extend radially outward from theproximal end of the graft.
 9. An endoluminal prosthesis comprising: agraft having a tubular body comprising proximal and distal ends; a valvereplacement disposed between the proximal and distal ends of the graft;at least one stent coupled to the graft, the at least one stent having acontracted delivery state and an expanded state for maintaining patencywithin a portion of the graft; at least one fenestration disposed in asidewall of the graft and pivotable in any direction away from an axisperpendicular to a longitudinal axis of the prosthesis; a firstperimeter having a first diameter and surrounding the at least onefenestration; a band of flexible material attached to and surroundingthe first perimeter and having a flexible frame; and a second perimeterattached to and surrounding the band of flexible material and having asecond diameter greater than the first perimeter diameter; where theband of material has a first diameter substantially the same as thefirst perimeter diameter and a second diameter substantially the same asthe diameter of the second perimeter, and where the diameter of the bandof material decreases in a direction away from the surface of the graftfrom the second perimeter to the first perimeter, wherein the band ofmaterial is configured to independently move between an interior surfaceof the graft and an exterior surface of the graft, and wherein theflexible frame extends about a surface of the band from the firstperimeter to the second perimeter.
 10. The endoluminal prosthesis ofclaim 9 where the at least one fenestration is disposed at a locationdistal to the valve replacement.
 11. The endoluminal prosthesis of claim9 wherein the band of material has a concave or convex orientationrelative to the surface of the graft.
 12. The endoluminal prosthesis ofclaim 9 wherein first and second fenestrations are disposed in the graftat locations between about 90 and about 270 degrees apart.
 13. Anendoluminal prosthesis comprising: a graft having a tubular bodycomprising proximal and distal ends; a valve replacement disposedbetween the proximal and distal ends of the graft; at least one stentcoupled to the graft, the at least one stent having a contracteddelivery state and an expanded state for maintaining patency within aportion of the graft; first and second fenestrations disposed in thegraft at locations between about 90 and about 270 degrees apart; a firstbranch vessel prosthesis extending between the first fenestration and aright coronary artery in a deployed state, and a second branch vesselprosthesis extending between the second fenestration and a left coronaryartery in the deployed state; a first perimeter having a first diameterand surrounding the first fenestration; a band of flexible materialattached to and surrounding the first perimeter and having a flexibleframe; and a second perimeter attached to and surrounding the band offlexible material and having a second diameter greater than the firstperimeter diameter; where the band of material has a first diametersubstantially the same as the first perimeter diameter and a seconddiameter substantially the same as the diameter of the second perimeter,and where the diameter of the band of material decreases in a directionaway from the surface of the graft from the second perimeter to thefirst perimeter, wherein the band of material is configured toindependently move between an interior surface of the graft and anexterior surface of the graft, and wherein the flexible frame extendsabout a surface of the band from the first perimeter to the secondperimeter.
 14. The endoluminal prosthesis of claim 13 wherein the firstand second fenestrations are disposed at a location distal to the valvereplacement.
 15. The endoluminal prosthesis of claim 13 wherein each ofthe first and second fenestrations are pivotable in any direction awayfrom an axis perpendicular to a longitudinal axis of the prosthesis. 16.The endoluminal prosthesis of claim 13 wherein the valve replacementcomprises an artificial valve having a tricuspid shape.